Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Peking University People's Hospital100 enrolled

Overview

To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.

Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Intertrochanteric Fractures

Interventions

Joint replacement surgeryPROCEDURE

Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.

Intramedullary nail fixationPROCEDURE

Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Intertrochanteric fractures of the femur need surgery * Male and female, age more than 75 years old * Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders * The patient is still able to tolerate surgery through the anaesthesia and related department assessment * Signed written informed consent Exclusion Criteria: * No complications associated with internal medicine * Mild fracture displacement and conservative treatment required * Multiple trauma involving more than one organ system * Known to have progressive malignant neoplasms * It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study

Locations (1)

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

Bleeding related index

Postoperative drainage volume and bleeding volume during operation（Unit: ml）

Time frame: Three days after the operation

Secondary Outcomes

Joint rehabilitation index

Early loading time

Time frame: Three months after the operation

Complication rate

The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality

Time frame: Three monthes after the operation

Functional rehabilitation index

Harris Scores of the two groups

Time frame: Three months after the operation

Surgical related index

operation time of the two groups（Unit: minutes）

Time frame: Three days after the operation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.